MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-03-20 for MEDPOR IMPLANT 8438 manufactured by Porex Surgical.
[836851]
The doctor stated that the patient received a medpor micro thin sheet implant in 2005. The doctor stated that the patient presented with an infection approximately 4 to 6 weeks prior to removing the implant. The doctor treated the infection with antibiotics. The doctor reported that the implant was removed in 2006 because of rejection of the implant. The doctor stated that he placed a septum button after removing the medpor micro thin sheet.
Patient Sequence No: 1, Text Type: D, B5
[7948683]
Following a review of the device history record, it was determined that all processes and test criteria are within the medpor implant finished product specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2008-00008 |
| MDR Report Key | 1017127 |
| Report Source | 05 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-13 |
| Date of Event | 2005-11-08 |
| Date Mfgr Received | 2008-02-12 |
| Device Manufacturer Date | 2005-06-04 |
| Date Added to Maude | 2009-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265 |
| Manufacturer Country | US |
| Manufacturer Postal | 30265 |
| Manufacturer Phone | 6784791610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR IMPLANT |
| Generic Name | FACIAL RECONSTRUCTION |
| Product Code | JOF |
| Date Received | 2008-03-20 |
| Model Number | NA |
| Catalog Number | 8438 |
| Lot Number | A171E11 |
| ID Number | NA |
| Device Expiration Date | 2015-06-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | 15 DART ROAD NEWNAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-20 |